News

FEATURED STORIES
While the pathogen appears unlikely to trigger a pandemic, analysts see potential for Moderna to build goodwill amid a period of political pressure on vaccine manufacturers.
Clinical trial setbacks have limited the near-term opportunities for some of Daiichi Sankyo’s ADCs but the drug developer is betting near-term readouts will catapult it into the top tier of oncology companies in the coming years.
BioSpace analyzed the pay ratio across 10 major pharmaceutical companies to determine which CEOs were paid the most relative to typical employees. J&J, Eli Lilly and Pfizer once again topped the list.
FROM OUR EDITORS
Read our takes on the biggest stories happening in the industry.
The Department of Health and Human Services is spinning its wheels, unable to establish steady leadership at three major divisions—the CDC and the FDA’s two primary review units.
THE LATEST
The U.S. Attorney’s Office was busy indicting nine people for charges related to insider trading. Some charges were unrelated, but three were specific to the biopharma industry.
The biotech industry is facing what some consider the worst times since its inception. Several market analysts recently shared their thoughts.
Here’s a look at global biopharma company news stories including Rona Therapeutics, Genuine Bio and NEOsphere Bio.
The transaction, Ginkgo’s largest acquisition to date, is expected to close by the first quarter of 2023, subject to regulatory approval and other closing conditions.
FDA
The complaint alleges the agencies made an error under the Administrative Procedure Act, violating the Food Drug and Cosmetics Act by failing to approve Lumryz.
Daiichi-Sankyo and AstraZeneca’s sBLA for HER2 directed Enhertu accepted by FDA. Novartis gets BLA acceptance for MS biosimilar. HOOKIPA’s IND for prostate cancer immunotherapy candidate accepted
A study published this month in Science discusses data that may support a devious alter ego of T-cells present within colorectal cancers that appear to inhibit and promote tumor progression.
The announcement signals that the WHO now views the outbreak as significant enough that a coordinated global response is necessary to control it.
Replay features next-generation genomic medicine technologies in its portfolio to address the needs of diseases that have large unmet needs.
FDA
FDA Weekly Review looks at the FDA’s actions related to drug approvals, IND approvals, designations and more. Here’s a look at what happened this week.